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| Credit Taiwan FDA |
#13,706
In a follow up to Tuesday's report Taiwan FDA & HK HA Reject 2 Batches Of Sanofi Flu Vaccine For `Impurities', Hong Kong's CHP has issued the following update indicating that no similar `contaminants' have been found among 1000 randomly selected samples checked in Hong Kong.
Use of the suspected lot remains suspended, and more quality checks are underway. New batches of vaccine have been ordered from Sanofi and another supplier, and no adverse reactions due to contaminants have been reported.While reports of flu activity have started to increase in South Korea and Canada, so far Hong Kong reports only low levels of Flu (see Flu Express Week 47).
The Department of Health (DH) announced today (November 29) the latest follow-up actions taken on quadrivalent seasonal influenza vaccines (SIVs), following its announcement concerning the suspension of supply of a batch of quadrivalent SIVs and the dispatch arrangements of another batch of vaccines by a licensed drug wholesaler, Sanofi-Aventis Hong Kong Limited (Sanofi), this Tuesday (November 27).
The DH collected over 1 000 samples of quadrivalent SIVs by Sanofi from Sanofi's storehouse and dispensaries of the DH clinics for inspection on a random basis yesterday (November 28). Among them, about 700 samples were from the affected batch while about 300 samples were from other batches. The inspection result revealed that no particles were detected in the samples.
Meanwhile, the DH has also collected vaccine samples for quality testing by the Government Laboratory and accredited laboratories. The results will be announced as soon as possible.
Preliminary information by Sanofi also revealed that it has not received any report regarding the presence of white particles in the same batch of SIVs currently supplied to Hong Kong, and that there is so far no evidence showing that the quality, safety or efficacy of the SIVs supplied to Hong Kong have been affected, or that safety risk is imposed to those receiving the vaccines. The DH has requested Sanofi to submit a full investigation report regarding the presence of white particles in the affected batch of SIVs.
"We have been working on the incident in the past days and have traced and compiled further information on the distribution locations of the affected batch of vaccines. The information, including a list of the DH's clinics, the Hospital Authority (HA)'s clinics, and other healthcare facilities, has been uploaded to the website of the Centre for Health Protection (www.chp.gov.hk/en/features/101125.html)," a spokesman for the DH said.
The HA has set up a hotline (2300 6028) and the DH has also set up a hotline (2125 1133). Members of the public may call the hotline during office hours, Monday to Friday, for enquiries.
Regarding the healthcare facilities supplied with the affected batch of SIVs, the DH has already instructed them to suspend the use of the affected vaccines, and to seal and not to use the remaining unused vaccines until the DH's further instruction.
To maintain a stable supply of SIVs, the DH has been keeping close contact with Sanofi and closely monitoring the progress of the dispatch arrangements of vaccines. The DH has also asked Sanofi and another supplier providing quadrivalent SIVs to Hong Kong to import additional quantities of vaccines to meet the local demand.
The spokesman stressed that the use of the affected batch of SIVs has been suspended and reminded the public that vaccination is one of the most effective ways to prevent influenza to protect themselves against influenza and its complications.
Ends/Thursday, November 29, 2018Issued at HKT 19:53
